Scientific Officer

Job

Are you interested to become our Akkodis Life Sciences new Scientific Consultant? Have you completed a Master’s degree in Life Sciences or related? Do you have experience in Regulatory Affairs, centralised procedure, and experience in liaising with regulatory authorities and public health authorities? Do you speak 2 European languages fluently? Then this position could be an interesting position for you!

Role summary

As a Scientific Officer/Product Lead you will be working in the Human Division, Therapeutic area. You will be responsible for ensuring that high quality, consistent scientific, regulatory and procedural input is provided, throughout the product lifecycle.

Your role

As a Scientific Officer/Product Lead you will be responsible for:

Development, evaluation and surveillance of medicinal products for human or veterinary use and of Maximum Residue Limits for substances for veterinary use;
Referrals and related procedures for medicinal products for human or veterinary use;
Management of requests for scientific advice, protocol assistance, parallel scientific advice with other decision makers (e.g. FDA or HTA bodies), as well as qualifications;
Preparing the summary report and supporting the coordination of the initial assessment for orphan medicine designation, paediatric investigation plans or limited markets classifications;
The delivery of high-quality product information through assessment of invented names, product information and its translations, mock-ups and specimens, and provision of advice and training on product information guideline principles;
Apply EU pharmaceutical legislation to the operations of the agency as required;
Lead to the development of regulatory and/or procedural guidance documents and provide training as required;
Coordinate and supervise the operation of Scientific Committee meetings, Working Parties, Working Groups, Advisory/Expert Groups, etc and related activities;
Respond to the requests for information received by the EMA in the scientific field;
Management of a portfolio of products throughout the product life cycle; from initial marketing authorisation (including pre-submission) and through post-authorisation;
Regulatory and scientific support to scientific committees, the Agency, the EU network of experts, the European Commission, and interactions with stakeholders;
Contribute to ensure high-quality of EPAR and product information for assigned product portfolio, from clinical/non-clinical perspective.

Profile

Your profile

We are looking for candidates with the following certification and skill set:

Education:

Bachelor or Master’s degree in Life Sciences (Biology, Chemistry, Biochemistry, Pharmacy, Medicine), which corresponds to completed university studies of at least three years attested by a diploma;
After obtaining Bachelor or Master’s degree up to 3 years of professionals relevant experience, experience in either a competent authority in the field of medicines regulation, the pharmaceutical industry or in a healthcare / academic setting should have been obtained in:
In the scientific, regulatory, or procedural aspects of the research, development, authorisation, productions or supervision of human or veterinary medicines;
In working with medicinal products containing medical devices and associated regulatory framework.

Experience and knowledge:

In regulatory affairs on EU-wide or national procedures or other work on the regulation of medicines;
In information analysis and reporting on scientific/regulatory matters;
Clinical experience in a therapeutic field;
In working for a multinational organisation and managing multiple international stakeholders;
Nonclinical experience in a Good Laboratory Practice (GLP) laboratory;
Understanding of medicines regulation;
Regulatory Affairs experience

Benefits

What do we offer?

Employment for 40 hours per week and the opportunity to work at innovative and progressing companies. You will be part of a fast-growing Life Sciences team that is represented in different industries (biotech, pharma, food) and present in Life Sciences clusters in The Netherlands.

Attractive salary of €4.564,31, depending on experience and education, more than 5 years of paid full time working experience your salary would be €5.164,29 gross per month;
The opportunity to work at the European Medicines Agency;
Work-life balance with 24 to 36 holidays;
Company fitness, health insurance and good pension scheme;
Annual team events;
Options to attend training, coaching and a personal development scheme;
Career opportunities matching your aspirations and development.

Company profile

About Akkodis

We are Akkodis. We put the talents, skills and ambitions of our Consultants first. Because we continuously offer you challenging projects, you continue to develop and you can realize your ambitions. This is our view on good employment practices. We, Akkodis Life Sciences, offer you internal and external projects in the field of QA, QC, PV, RA, R&D, Supply Chain and related.

We have > 60 Consultants working at the EMA, Astellas, GSK, Unilever, Corbion, MSD, Organon, Aspen and many more

Contact

Are you interested in this challenge, or do you want to come in touch?

Please apply via one of the Talent Acquisition Specialist and send your CV to esciences@akkodisgroup.com">lifesciences@akkodisgroup.com and include the following information in your profile: